From a purely technical point of view some single-use medical implants such as for example cardiac pacemakers, defibrillators or electrodes can in principle also be re-used or put to further use after explantation of those implants out of a patient. Explanation of implants is effected for example upon a change in medical indication or after the decease of a patient.
It happens that implants of that kind are restored again after explantation. For that purpose the implant is cleaned, disinfected and sterilised. Such re-use is generally effected without the knowledge of the patient and without approval from the manufacturer.
In regard to the development and manufacture of medical products for one-time use, it will be appreciated that there are numerous aspects to be taken into account, which can influence the safety and efficiency of such products. Those aspects include for example previous germ contamination of the product, the behaviour of the material in regard to use, compatibility of product, packaging and sterilisation process, durability period of the materials and durability period of the sealing seams of the sterile packaging. In contrast to a manufacturer, restorers frequently do not have those important items of information.
After use of the implant and subsequent restoration by cleaning, disinfecting and sterilisation, those medical products may suffer from deficiencies. Such deficiencies may involve inter alia the existence of microcracks, inadequate freedom from germs, inadequate freedom from pyrogens, the presence of particles and endotoxins, an impairment in material properties, consumption of the batteries, the loss of electrical safety and the occurrence of dangerous substances due to cleaning and re-sterilisation.
Therefore, in spite of implants of that kind having been reprocessed, the re-use thereof still entails some dangers. It is not possible to exclude the functional capability being adversely affected or a reduction in the remaining operational service life by virtue of the period of use which has already elapsed or patient infection. The risks which occur as a result of this are on the one hand ethically unjustifiable and on the other hand they can give rise to product liability problems.
Therefore the object of the present invention is to provide electrical therapy devices and medical implants which can prevent unauthorised re-use.